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The NexGen® TMT Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.

The NexGen TMT Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE). These tibial components are intended for use with Zimmer NexGen CR Femoral Components.

This document is a 510(k) Pre-Market Notification for a medical device called "The NexGen TMT Tibia." This type of submission to the FDA is for demonstrating that a new device is substantially equivalent to a legally marketed predicate device, rather than for proving efficacy through clinical trials. It does not contain the kind of detailed study information typically found in submissions for novel AI/medical imaging devices, which often involve specific acceptance criteria and performance metrics.

Therefore, many of the requested categories about acceptance criteria, study design, expert involvement, and reader studies are not applicable or cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or explicitly stated based on the given document:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or provide performance metrics in the way one would see for an AI device. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and safety and effectiveness profile.

The reported "performance" is that the device is deemed substantially equivalent to identified predicate devices, as stated in the Conclusion: "The NexGen TMT Tibia is substantially equivalent to the identified predicate devices." The FDA's letter confirms this with: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission focused on substantial equivalence to predicate devices, not on a clinical or performance study with a test set of patient data to measure diagnostic accuracy or similar metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission does not describe a study involving human experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (a knee implant component), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate device. The new device is compared against this established standard. There is no specific patient-level "ground truth" in the context of a typical AI/diagnostic study.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI device.

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